SITE001-0376

completed

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer · Phase III
SITE001 (USA) · Dr. Reyes
consented 2023-05-11

AEs

Serious

Dropout signal

–

Adverse events

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-07-10 (study day 43); relationship: N; serious criteria: life-threatening

mild assessed

Grade 1 Dyspnoea — outcome: UNKNOWN; onset 2023-08-11 (study day 75); relationship: N

moderate assessed

Grade 2 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-08-17 (study day 81); relationship: Y

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-04-09 (study day 317); relationship: N

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-07-10 (study day 409); relationship: N

severe serious assessed

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-10-06 (study day 497); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-11-18 (study day 540); relationship: N

Data queries

No data queries.